K243302
- 510(k) number
- K243302
- Device name
- 3DMatrix DynaFlex (DynaFlex)
- Applicant
- Printbio, Inc. NY · US
- Product code
- OXF — Mesh, Surgical, Absorbable, Plastic And Reconstructi
- Decision date
- 2025-05-21
- Date received
- 2024-10-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K243302.pdf
Official FDA record: K243302
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.